KCTL

Medical Equipment

Global Certification

Safety

MET
EU MDR
GMA

MET

MET is the first OSHA-recognized NRTL (Nationally Recognized Testing Laboratory) in the United States. NRTL certification provides clear evidence that your electrical and electronic products comply with the required standards of the North American market. The MET Mark clearly indicates compliance to US and Canadian requirements.

It helps access not only the North American market but also the global market through the global network of Eurofins Group. Eurofins global offers an overall solution to various regulations, including safety, EMC and energy efficiency testing.

대상품목

01 EV Charger
02 ATM Machine
03 Industrial Machine
04 Industrial Vacuum Pump
05 Industrial components
06 Household Equipment
07 AV/IT Product

SERVICE AREA

• Product Safety Certification for US-NRTL

• Canada SCC, and IECEE-CB Scheme, with testing and reporting for EU-CE

• On-site Field Evaluation, Labelling and LPC(Limited Production Certification)

• Reliability Reporting Service

• Medical test, Factory automation test,

• ATEX/IECex/HazLoc for explosion proof equipment(Europe, Asia and USA)

• Energy Efficiency Testing & Certification (USA)

• Telecom / NEBS Testing

• CE LVD, MD (Machinery Directive)

• Semiconductor machine for SEMI S2, S6, S8, S22, F47

SERVICE PROCESS

STEP 01

Application
STEP 02

Confirmation of document and prodcut
STEP 03

Progress test

STEP 04

Issue draft report
STEP 05

Initial inspection
STEP 06

Issue final report & certificate

CONTACT

Please contact us for more information.

Phone NO. 070-4652-4400
E-mail CKR011_met@cpt.eurofinsasia.com

EU Medical Device Regulation

In order to legally CE mark and sell their products in EU market, Manufacturers shall be comply with the Medical Device Regulation (EU) 2017/745 (MDR) and updated and Common Specification.

Eurofins, as European Medical Device Notified Body(n° 0477) and Certification Body(n° 133A), is able to support Customers in finding the right certification path and in the certification process for Medical Devices (Active and Non-Active).

대상품목

01 Active non-implantable devices for imaging,
monitoring and/or diagnosis
02 Active non-implantable therapeutic devices and
general active non-implantable devices
03 Non-active implants and
long term surgically invasive devices
04 Non-active
non-implantable devices

SERVICE AREA

• EU MDR 2017/745, Conformity assessment procedure_ technical documentation assessment

• EN ISO 13485, Conformity assessment procedure_ onsite audit

• Medical device biocompatibility test (GLP Compliance, Biocompatibility Testing, ISO 10993-1 and Normative reference ISO 10993-XX)

• Training (EU MDR, Risk management (ISO 14971, ISO/TR 24971), Usability, Internal auditor, Clinical evaluation, MDSAP, Design and development process, How to create a Technical Documentation)

SERVICE PROCESS

STEP 01

Application
STEP 02

Confirmation of technical document

STEP 03

Conformity assessment, audit and issue the certificate
STEP 04

Surveillance and unannounced audit

CONTACT

Please contact us for more information.

Phone NO. 070-4652-4404
E-mail CKR011_eumdr@cpt.eurofinsasia.com

GMA Global Market Access

The requirements for a given product are quite different around the world. A correct certification is required before a product is sold in the particular country.

Eurofins KCTL helps clients to obtain the required certifications and approvals for 200 countries.